Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter E8IVL080080
Listed
Valid until
Not applicable
FDA recalls
None foundDocuments
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00195451001093 | Date29 Sep 2026 | StatusListed |
Recalls
No FDA recalls found in the data synced 23 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Shockwave IVL System with the Shockwave E8 Peripheral IVL Catheter
- Generic Name
- Intravascular lithotripsy system catheter, balloon, peripheral
- Model / Ref / Catalog
- E8IVL080080
- Primary DI / UDI-DI
- 00195451001093
- 510(k) Number
- FDA Product Code
- PPN
- GMDN Term
- Intravascular lithotripsy system catheter, balloon, peripheral
- Device Class
- Class II
- Regulation Number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
- Size
- Balloon Diameter — 8.0 MillimeterBalloon Length — 80 MillimeterCatheter Length — 150 CentimeterGuidewire Diameter — 0.36 MillimeterIntroducer Sheath Compatibility — 7 French
From the manufacturer
Manufacturer's product page: Shockwave IVL System
Other devices from Shockwave Medical Inc.
Properties
Other properties (9)
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No